Mediana P10 Manual de Serviço Página 108

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102
No Calibration Required (Mediana module)
Pulse oximeter requires neither production, nor user calibration. The relationship between
light absorption by hemoglobin and reported SpO
2
is stored in the device memory during
manufacturing of the device. This relationship is established for given LED wavelengths
and given sensor construction, by comparison with blood gas measurements, using
statistically significant number of samples.
Measured versus Calculated Saturation
The measured SpO
2
value from an oximeter may differ from the saturation value that is
calculated from a blood gas partial pressure of oxygen (PO
2
). This usually occurs
because the calculated saturation was not appropriately corrected for the effects of
variables that shift the relationship between PO
2
and saturation: pH, temperature, partial
pressure of carbon dioxide (PCO
2
), 2, 3-DPG, and fetal hemoglobin.
100
50
0
50 100
Saturation (%)
PO2 (mmHg)
pH
Temperature
PCO2
2,3-DPG
Fetal Hb
pH
Temperature
PCO
2
2,3-DPG
Figure 42. Oxyhemoglobin Dissociation Curve
Functional versus Fractional Saturation
This monitor measures functional saturation — oxygenated hemoglobin expressed as a
percentage of the hemoglobin that can transport oxygen. It does not detect significant
amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In
contrast, hemoximeters such as the IL482 report fractional saturation — oxygenated
hemoglobin expressed as a percentage of all measured hemoglobin, including measured
dysfunctional hemoglobin. To compare functional saturation measurements to those from
an instrument that measures fractional saturation, fractional measurements must be
converted as follows:
functional saturation = fractional saturation
100 (%carboxyhemoglobin + %methemoglobin)
SpO
2
Accuracy (Nellcor module)
The saturation (SpO
2
) accuracy specification and/or pulse rate (PR) performance were
analyzed by comparative oximetry performance (COPS) tests between M30 SpO
2
module
and MP506 module with the same version of the oximetry algorithm from Nellcor
®
.
This
was to demonstrate that the performance of M30 SpO
2
module was equivalent to that of
MP506, which had been validated during both standard motion, combined motion and
cold-induced peripheral vasoconstriction (low perfusion) conditions by direct comparison
to measurements of arterial oxygen saturation (SaO
2
) obtained from arterial blood
samples analyzed with Instrumentation Laboratory (IL) CO-Oximeters under Nellcor’s
clinical protocol, Invasive Controlled Hypoxia Studies.
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